US10555729B1 - Flush anchor snap-off method - Google Patents

Abstract

A method for anchoring one or more tensile members to bone includes: providing an anchor, including: a housing including a body portion and an extension portion interconnected by a breakaway structure which is configured to retain structural integrity under a first predetermined tensile load and to separate under a second predetermined tensile load which is greater than the first predetermined tensile load; a collet disposed in the hollow interior; and a sleeve movable parallel to the central axis between first and second positions; passing one or more tensile members through a central bore of the collet; seating the housing into a bore formed in the bone; and driving the sleeve from the first position towards the second position under the first predetermined tensile load, so as to swage the collet around the one or more tensile members.

Description

BACKGROUND OF THE INVENTION

This invention relates generally to medical implants, and more particularly to a method for applying tension along or across a ligament to repair, augment, or replace it, or applying tension across a bone fracture to reduce it.

Medical implants for tensioning purposes typically comprise one or more tensile members (e.g., sutures or orthopedic cables) connected to one or more anchors (e.g., suture anchors or suture locks) to create a converging tensile force between the two anchors. This general concept has been used in the orthopedic and sports medicine fields to repair torn or damaged tendons and ligaments, to replace missing or displaced tendons and ligaments, and to anchor grafted or artificial tendons and ligaments to bones so that they can grow back together.

Prior art anchor/tensile member configurations typically fall into three functional categories; (1) a configuration in which the tensile member in held in place by an interference fit between the tensile member and bone, (2) a configuration in which the tensile member is tied, glued, melted, or otherwise connected to the anchor during manufacturing or intraoperatively, and (3) a configuration in which the tensile member is tensioned or made tight with the use of one of many available and well-known slip-knots.

It is often desirable to have the ability to tension the configuration provisionally (i.e. without setting a final irreversible tension) so that the effect of a particular level of tension can be evaluated and have the opportunity to “settle in” before it is made permanent.

However, one problem with prior art anchors is that they do not generally permit accurate provisional tensioning. When standard suture anchors are used, the tension is set by estimating the length of the final suture implant or tying a slipknot that can be tightened by hand. Some are even tensioned by wrapping the suture around a Kirschner wire (“K-wire”) and twisting the wire to tighten. Even if the initial tension is estimated well, suture will settle into the soft tissue around it and lose tension after implantation. There does not currently exist a good way to tension a suture to a known load, “trial” its tension and allow for some settle in, re-tension, and repeat as needed.

Another problem with prior art suture tensioning techniques is that of determining that excessive tension is our applied. More specifically, because the tension in a suture strand does not exceed its failure load during the operative procedure does not mean it will not experience a load greater than its failure load during cyclic loading in-situ.

BRIEF SUMMARY OF THE INVENTION

At least one of these problems are addressed by a modular orthopedic device, and implant/instrument system, and method that includes a bone anchor device that is used to secure a tensile member under tension.

According to one aspect of the technology described herein, a method is provided for anchoring one or more tensile members to bone, including: providing an anchor, including: a housing extending along a central axis between open first and second ends, and having a hollow interior, the housing including a body portion and an extension portion interconnected by a breakaway structure which is configured to retain structural integrity under a first predetermined tensile load and to separate under a second predetermined tensile load which is greater than the first predetermined tensile load; a collet disposed in the hollow interior of the body portion, the collet having a peripheral wall defining a central bore for accepting a tensile member therethrough and an exterior surface, wherein the collet is configured to be swaged around and against the tensile member; a sleeve having a peripheral wall defining opposed interior and exterior surfaces, the sleeve disposed in the hollow interior of the housing and positioned generally axially adjacent to the collet, so as to be movable parallel to the central axis between first and second positions; and wherein at least one of the exterior surface of the collet and the interior surface of the sleeve is tapered and the sleeve and the collet are arranged such that movement of the sleeve from the first position to the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around and against the tensile member; passing one or more tensile members through the central bore of the collet; seating the housing into a bore formed in the bone; and driving the sleeve from the first position towards the second position under the first predetermined tensile load, so as to swage the collet around the one or more tensile members.

According to another aspect of the technology described herein, a method is provided for anchoring tensile members to a joint, including: inserting a first tensile member having first and second ends into a first passage having first and second ends in a first bone; securing the first end of the first tensile member in the first end of the first passage, using a first anchoring element; inserting a second tensile member having first and second ends into a second passage having first and second ends in the first bone; securing the first end of the second tensile member in the first end of the second passage, using a second anchoring element; passing the second ends of both first and second tensile members through a third passage formed in a second bone; providing a third anchoring element, comprising an anchor which includes: a housing extending along a central axis between open first and second ends, and having a hollow interior; a collet disposed in the hollow interior of the housing, the collet having a peripheral wall defining a central bore for accepting a tensile member therethrough and an exterior surface, wherein the collet is configured to be swaged around and against the tensile members; a sleeve having a peripheral wall defining opposed interior and exterior surfaces, the sleeve disposed in the hollow interior of the housing and positioned generally axially adjacent to the collet, so as to be movable parallel to the central axis between first and second positions; and wherein at least one of the exterior surface of the collet and the interior surface of the sleeve is tapered and the sleeve and the collet are arranged such that movement of the sleeve from the first position towards the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around and against the tensile members; passing the second ends of the first and second tensile members through the central bore of the collet; seating the housing into the second bone; applying a first final tension to the first tensile member; applying a second final tension to the second tensile member; and driving the sleeve from the first position towards the second position, thus swaging the collet around the second ends of the first and second tensile members.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be best understood by reference to the following description taken in conjunction with the accompanying drawing figures in which:

FIG. 1 is a schematic side elevation view of a segment of a prior art tensile member;

FIG. 2 is cross-sectional view of an assembled anchor with a tensile member engaged therein;

FIG. 3 is an exploded view of the anchor ofFIG. 2;

FIG. 4 is a cross-sectional view ofFIG. 3;

FIG. 5 is a schematic cross-sectional view of a housing having a flange disposed at an oblique angle;

FIG. 6 is a schematic side elevation view of a housing having an exterior surface including male threads;

FIG. 7 is a schematic side elevation view of a housing having an exterior surface including a surface coating;

FIG. 8 is a schematic side elevation view of a housing having an exterior surface incorporating knurling;

FIG. 9 is a schematic cross-sectional view of a housing having female threads engaging an instrument having male threads;

FIG. 10 is a schematic cross-sectional view of a housing having male threads engaging an instrument having female threads;

FIGS. 11 and 12 are schematic cross-sectional views of a housing having bayonet fitting slots engaging bayonet lugs of a corresponding instrument;

FIGS. 13 and 14 are schematic cross-sectional and top plan views, respectively of a housing having a circumferential slot engaging axial lugs of a corresponding instrument;

FIG. 15 is a schematic cross-sectional view of a housing having a counterbore formed therein engaging collet jaws of a corresponding instrument;

FIGS. 16 and 17 are schematic side elevation and cross-sectional views, respectively of a housing having a break-away connection to a corresponding instrument;

FIG. 18 is a schematic cross-sectional view of a housing having a tapered sleeve retention feature;

FIG. 19 is a schematic cross-sectional view of a housing having a snap ring sleeve retention feature;

FIG. 20 is a schematic cross-sectional view of a housing having resilient sleeve retention tabs;

FIGS. 21 and 22 are schematic cross-sectional and end views, respectively, of a collet having a slotted construction;

FIGS. 23 and 24 are schematic cross-sectional and end views, respectively, of a collet having curvilinear slots formed therein;

FIGS. 25 and 26 are schematic cross-sectional and end views, respectively, of a collet having a spring structure

FIG. 27 is a schematic cross-sectional view of a sleeve having a double taper interior surface;

FIG. 28 is a schematic cross-sectional view of a sleeve having a scaled interior surface;

FIG. 29 is a schematic cross-sectional view of a sleeve having an integral snap ring interior surface;

FIG. 30 is an exploded view of another exemplary embodiment of an anchor;

FIG. 31 is a cross-sectional view ofFIG. 30;

FIG. 32 is a schematic side elevation view of a portion of the anchor ofFIG. 30 in a compressed condition;

FIG. 33 is a cross-sectional view ofFIG. 32;

FIG. 34 is a cross-sectional view of the anchorFIG. 30 in an assembled condition, before compression;

FIG. 35 is a sectional view taken along lines35-35 ofFIG. 34;

FIG. 36 is a cross-sectional view of the anchorFIG. 30 in a compressed condition;

FIG. 37 is a sectional view taken along lines37-37 ofFIG. 36;

FIG. 38 is a schematic, partially-sectioned perspective view of an exemplary anchor having an integral collet;

FIG. 39 is a schematic, partially-sectioned perspective view of an exemplary anchor having an integral collet and sleeve;

FIG. 40 is a schematic side elevation view of an exemplary housing assembled with a snap-on cap;

FIG. 41 is a sectional view of the housing and cap ofFIG. 40;

FIG. 42 is a schematic exploded perspective view of an exemplary housing assembled with a screw-on cap;

FIG. 43 is a sectional view of the housing and cap ofFIG. 42;

FIG. 44 is a schematic perspective view of an installation instrument for use with the anchor described herein;

FIG. 45 is an exploded view of the installation instrument ofFIG. 44;

FIG. 46 is a schematic side elevation view of the installation instrument ofFIG. 44, with a tensioner attached thereto;

FIG. 47 is a schematic cross-sectional view of a distal end of the stem of the installation instrument ofFIG. 44, with jaws thereof in an open position;

FIG. 48 is a view of the stem shown inFIG. 44, with jaws thereof in a closed position;

FIG. 49 is a schematic cross-sectional view of a distal end of the stem of the installation instrument ofFIG. 44, showing an anchor loaded therein;

FIG. 50 is a view of the stem ofFIG. 49, showing a clip in an engaged position;

FIG. 51 is another view of the stem ofFIG. 49, showing a pushrod thereof being actuated;

FIG. 52 is another view of the stem ofFIG. 49, showing a clip in a released position, with the jaws opened to release the anchor;

FIG. 53 is a schematic cross-sectional view of a distal end of a stem of an alternative installation instrument of, showing an anchor ready to be loaded therein;

FIG. 54 is a view of the stem ofFIG. 53, showing an anchor lightly received in jaws of the stem, with a locking sleeve retracted;

FIG. 55 is another view of the stem ofFIG. 53, showing a locking sleeve pushed down over the jaws to secure the anchor;

FIGS. 56 and 57 are sequential views showing actuation of a pushrod of the stem ofFIG. 49;

FIG. 58 is another view of the stem ofFIG. 49, showing a clip in a released position, with the jaws opened to release the anchor;

FIG. 59 is a schematic cross-sectional view of an alternative embodiment of an installation instrument stem;

FIG. 60 is a schematic perspective view of an installation instrument having an alternative flexible stem;

FIG. 61 is a schematic view showing the installation instrument ofFIG. 60 being used in plan an anchor in a human need joint;

FIG. 62 is a schematic perspective view of a button anchor;

FIG. 63 is a schematic perspective view of a suture anchor;

FIG. 64 is a schematic perspective view of an anchor plate;

FIG. 65 is a schematic perspective view of a grommet;

FIG. 66 is a schematic diagram of a tensile member implanted in a human femur;

FIG. 67 is a schematic perspective view of a tensile member implanted in a human knee joint;

FIG. 68 is a schematic, partially-sectioned perspective view of an exemplary anchor having an integral internal member;

FIG. 69 is a schematic view showing an arthroscopic procedure in which a rigid stem is used to position an anchor in the pelvic region, close to the superficial surface of the skin;

FIG. 70 is a schematic view showing an arthroscopic procedure in which a rigid stem is used to position an anchor in the pelvic region, far from the superficial surface of the skin;

FIG. 71 illustrates an arthroscopic procedure in which a rigid stem is used to position an anchor in the knee region, close to the superficial surface of the skin;

FIG. 72 is a partially cutaway perspective view of an alternative embodiment of an anchor;

FIG. 73 is a side view of the anchor ofFIG. 72;

FIG. 74 is a schematic perspective exploded view of the anchor ofFIG. 72 in combination with an insertion instrument;

FIG. 75 is a sectioned perspective view of a portion of the anchor ofFIG. 72, showing a breakaway structure thereof;

FIG. 76 is an enlarged view of a portion ofFIG. 75;

FIG. 77 is a schematic cross-sectional view of the anchorFIG. 72 coupled to an insertion device, prior to a swaging operation;

FIG. 78 is a schematic cross-sectional view of the anchor ofFIG. 72, upon completion of a swaging operation;

FIG. 79 is a schematic cross-sectional view of the anchor ofFIG. 72, subsequent to completion of a swaging operation, showing an extension portion of the housing ofanchor72 being separated from the remainder of the anchor;

FIGS. 80-82 are schematic side, and, and enlarged partial sectional views, respectively, of a collet having a collapsible construction;

FIGS. 83-85 are schematic side, end, and enlarged partial sectional views, respectively, of the collet ofFIG. 82, in a collapsed condition;

FIG. 86 is a schematic perspective view an installation instrument, with a first embodiment of a multiple-strand tensioner attached thereto;

FIG. 87 is a schematic perspective view an installation instrument, with a second embodiment of a multiple-strand tensioner attached thereto;

FIG. 88 is a schematic perspective view of a tensile member cutting instrument;

FIG. 89 is a cross-sectional view of a portion of the cutting instrument ofFIG. 88 in an open position;

FIG. 90 is a cross-sectional view of a portion of the cutting instrument ofFIG. 88 in a closed position;

FIG. 91 is a cross-sectional view of a portion of an alternative cutting instrument in an open position;

FIG. 92 is a cross-sectional view of the cutting instrument ofFIG. 91 in a closed position;

FIG. 93 is a schematic perspective view of an operating mechanism suitable for actuating the cutting instrument shown inFIGS. 89-92;

FIG. 94 is a schematic perspective view of an anchor housing including suture holes in the flange thereof;

FIG. 95 is a schematic perspective view of an exemplary suture button;

FIG. 96 is a schematic perspective view of another exemplary suture button;

FIG. 97 is a schematic diagram showing reduction of a pelvic brim fracture;

FIG. 98 is a schematic diagram showing reduction of a tibial epicondyle fracture;

FIG. 99 is a schematic diagram showing reduction of a fibula fracture;

FIG. 100 is a schematic diagram showing tensioning of a rotator cuff against the proximal humerus;

FIG. 101 is a schematic diagram showing reduction of a clavicle fracture;

FIG. 102 is a schematic diagram showing reduction of a femoral epicondyle fracture;

FIGS. 103A, 103B, and 103C are schematic views of the medial, anterior, and lateral aspects, respectively of a human knee joint, showing a single strand lateral cruciate ligament augmentation;

FIGS. 104A, 104B, and 104C are schematic views of the medial, anterior, and lateral aspects of a human knee joint, showing a double bundle lateral cruciate ligament augmentation;

FIGS. 105A, 105B, and 105C are schematic views of the medial, interior, and lateral aspects, respectively of a human knee joint, showing a single strand medial cruciate ligament augmentation;

FIGS. 106A, 106B, and 106C are schematic views of the medial, anterior, and lateral aspects, respectively of a human knee joint, showing a double bundle medial cruciate ligament augmentation;

FIGS. 107A, 107B, and 107C are schematic views of the medial, anterior, and lateral aspects, respectively of a human knee joint, showing a double bundle anterior cruciate ligament augmentation;

FIGS. 108A, 108B, and 108C are schematic views of the medial, anterior, and lateral aspects, respectively of a human knee joint, showing a double bundle posterior cruciate ligament augmentation;

FIGS. 109A and 109B are schematic views of the lateral and medial aspects, respectively of the human foot, showing a double bundle ligament augmentation;

FIGS. 110A and 110B are schematic views of the lateral aspect of the human foot, showing a single strand forefoot correction;

FIGS. 111A and 111B are schematic views of the medial aspect of the human knee joint, in extension and flexion, respectively, and having a double-bundle ligament augmentation;

FIGS. 112A and 112B are schematic views of the medial aspect of the human knee joint, an extension and flexion, respectively and having a single-strand ligament augmentation;

FIGS. 113 and 114 are schematic side views of the medial aspect of a human knee joint showing targets for ligament augmentation drill locations superimposed thereupon;

FIGS. 115-117 are schematic views of a human knee joint showing a drill guide attached thereto;

FIG. 118 is a schematic side view of a clamp for a cerclage repair;

FIG. 119 is a schematic cross-sectional view of the clamp ofFIG. 118;

FIG. 120 is a schematic exploded perspective view of an alternative clamp for a cerclage repair;

FIG. 121 is a cross-sectional view of the clamp ofFIG. 120;

FIG. 122 is a schematic perspective view of the human femur having a cerclage applied thereto;

FIG. 123 is a schematic perspective view of a self-tracking reamer;

FIG. 124 is a front elevation view of the self-tracking reamer ofFIG. 122;

FIG. 125 is a side elevation view of the self-tracking reamer ofFIG. 122; are schematic views of the medial aspect of the human knee joint, in extension and flexion, respectively, and having a double-bundle ligament augmentation;

FIG. 126 is a schematic perspective view of the self-tracking ofFIG. 122 being used to ream out the canal of a bone;

FIG. 127 is a schematic side elevation view of a flangeless anchor housing;

FIG. 128 is a cross-sectional view of the anchor housing ofFIG. 127; and

FIG. 129 is a schematic view of the anterior aspect of a human knee joint having a double-bundle ligament augmentation using the anchor housing shown inFIGS. 127 and 128.

DETAILED DESCRIPTION OF THE INVENTION

In general, the technology described herein provides a modular device and implant system and method that enables provisional and permanently stable tensioning of the tensile member, with minimally-invasive access to and limited visualization of the bone surface, using a device that is small and low-profile to prevent stress-shielding and soft tissue hang-up, implanted by simple and intuitive instrumentation that optimizes workflow and can be accomplished by one person.

The anchor, installation system, and installation method described herein are suitable for receiving and securing a tensile member to bone. The term “tensile member” as used herein generally refers to any flexible element capable of transmitting a tensile force. Nonlimiting examples of known types of tensile members include sutures and orthopedic cables.FIG. 1 illustrates a short segment of a representativetensile member10 having a diameter “D1”. Commercially-available tensile members intended to be implanted in the human body may have a diameter “D1” ranging from tens of microns in diameter to multiple millimeters in diameter. Commercially-available tensile members may be made from a variety of materials such as polymers or metal alloys. Nonlimiting examples of suitable materials include absorbable polymers, nylon, ultrahigh molecular weight polyethylene (“UHMWPE”) or polypropylene titanium alloys, or stainless steel alloys. Known physical configurations of tensile members include monofilament, braided, twisted, woven, and wrapped.

FIG. 2 illustrates an exemplary embodiment of ananchor12. Theanchor12 includes three functional elements, namely ahousing14 configured to be implanted into bone, acollet16 received in thehousing14 and configured to be swaged around and against atensile member10 without moving axially relative to thehousing14 ortensile member10, and asleeve18 received in thehousing14 which is capable of moving axially within thehousing14 so as to swage thecollet16, thus retaining thetensile member10. (Some minimal axial movement of thecollet16 not significantly affecting tension may occur during swaging). Each of these basic elements is described in detail below with reference toFIGS. 3 and 4.

Thehousing14 has abody20 extending along a central axis “A” between first and second ends22,24. Thebody20 is defined by aperipheral wall26 having interior andexterior surfaces28,30 respectively, and defining ahollow interior29. In the illustrated example, thebody20 is generally cylindrical in shape. The first and second ends22,24 of thebody20 may be chamfered and/or radiused as illustrated or otherwise shaped to ease insertion into bone. The first end of thebody22 has aninternal flange31 which is sized to define a stop against axial motion of thecollet16.

A generallyannular flange32 is located at or near thesecond end24 and extends radially outwards from thebody20. Theflange32 defines lateral andaxial surfaces33,35 respectively. The size and shape of theflange32 may be selected to suit a particular application. In the example illustrated inFIG. 4, a reference plane “P” passing through theflange32 is oriented at an angle θ perpendicular to the central axis A. It will be understood that the orientation of the flange may be varied to suit a particular application. For example,FIG. 5 shows ahousing114 in which the angle θ is oblique to the central axis A.

Other means may be provided in order to permit theanchor12 to be implanted in various orientations. For example,FIGS. 127 and 128 illustrate ahousing5014 which lacks a flange as depicted in other embodiments. (Thehousing5014 may optionally include an extension portion and breakaway structure as described with respect to other anchor embodiments, not shown inFIG. 127 or 128). Anexterior surface5030 of thebody5020 of thehousing5014 is formed intomale threads5034. Alternatively,exterior surface5030 may be configured (in terms of structure, material selection, or both) according to one of the other embodiments shown inFIG. 6-8 to improve the connection between thehousing5014 and the bone. Stated another way, a maximum diameter of the housing is defined by an outer extent of thethreads5034. The lack of the flange extending beyond the outer extent of thethreads5034. The lack of the flange permits thehousing5014 to be implanted flush or sub-flush relative to the bone surface. More importantly, it permits it to be installed in a bore or passage which is oriented at any arbitrary angle relative to the surface of the bone. In such situations, if a flange were used, a gap would be present between at least some portions of the flange and the bone. Stated another way, the bore or passage in the bone can extend along an axis which is oblique to the surface of the bone. An example is shown inFIG. 129 whereinimplant having housing5014 is implanted into a human tibia T, in a passage which is oblique to the surface of the bone.

Theanchor12 may have an overall size which is generally small enough to be implanted inside a human body. In one example thehousing14 may be cylindrical in shape with an outside diameter “D2” of about 3 to 12 mm, and theflange32 may have an outside diameter “D3” about 5 to 20 mm.

Theexterior surface30 of thehousing14, specifically thebody20 may be configured (in terms of structure, material selection, or both) to improve the connection between thehousing14 and the bone. Examples of exterior surfaces configured to achieve this function are illustrated inFIGS. 6, 7, and 8.

FIG. 6 shows ahousing214 in which anexterior surface230 of the body is formed intomale threads34.

FIG. 7 shows ahousing314 in which anexterior surface330 of the body has acoating36 applied thereto which encourages bone growth. One example of a known type of coating that encourages bone growth and infiltration is an inorganic crystalline structure such as hydroxyapatite (“HA”).

FIG. 8 shows ahousing414 in which anexterior surface430 of the body has asurface texture38 incorporating areas which are relatively raised interspersed with areas that a relatively lowered. One example of a known type of surface texture is knurling.

Thehousing12 may be provided with means for securing it to bone. For example,FIG. 94 illustrates ahousing12 withholes4030 passing through theflange32. In use, a suture loop (not shown) may be passed around a bone or other part of a patient's body. Distal ends of the suture loop may be passed through theholes4030 and tied together to secure thehousing12 against the bone surface.

Thehousing14 may incorporate a connection feature configured to permit a secure, releasable connection to an instrument used for insertion or manipulation of theanchor12. Examples of connection features are illustrated inFIGS. 9-17.

FIG. 9 shows ahousing514 incorporatingfemale threads40 which engagemale threads42 of an insertion instrument (shown generically at “I”).

FIG. 10 shows ahousing614 having a flange incorporatingmale threads44 which engagefemale threads48 of an insertion instrument I.

FIGS. 11 and 12 show ahousing714 havinginternal slots50 which receiveexternal lugs52 formed on the periphery of an insertion instrument I, forming a “bayonet” type connection.

FIGS. 13 and 14 show ahousing814 havingcircumferential slots54 formed in theflange32 which receivecylindrical lugs55 formed on an end surface of an insertion instrument I.

FIG. 15 shows ahousing914 having acounterbore56 formed therein sized to receivecollet jaws58 formed on an insertion instrument I.

FIGS. 16 and 17 show ahousing964 connected to a distal end of an insertion instrument I by anintegral collar965 which is perforated withopenings966. In use, insertion instrument I may be used to implant thehousing964, and secure thetensile member10. Thecollar965 may then be fractured in order to detach insertion instrument I. This may be described as a “breakaway” or “snap-off” connection.

Thehousing14 may incorporate a sleeve retention feature configured to retain thesleeve18 in an activated position. These features interact with retention features of thesleeve18 which are described in more detail below. Examples of sleeve retention features are illustrated inFIGS. 18-20.

FIG. 18 shows ahousing1014 incorporating a taperedsection60 in theinterior surface1028 of the peripheral wall. The taperedsection60 is located near thefirst end1022 of the body1020.

FIG. 19 shows a housing1114 in which theinterior surface1128 of the peripheral wall1126 incorporates acircumferential groove62 which receives aresilient snap ring64.

FIG. 20 shows ahousing1214 in which the peripheral wall1226 defines one or more integralresilient locking tabs66 that extend radially inward.

Thehousing14 may be made from any material which is biocompatible and which will engage the other elements so as to transfer tensile force thereto. As used herein, the term “biocompatible” refers to a material which is not harmful to living tissue. Nonlimiting examples of suitable materials for thehousing14 include polymers and metal alloys. Nonlimiting example of suitable metal alloys include stainless steel alloys and titanium alloys. Thehousing14 may be fabricated by a technique such as machining, forging, casting, sintering, or additive manufacturing (e.g., “3D printing”). Optionally, thehousing14 may comprise a porous material.

Thehousing14 may be treated with known coating such as titanium nitride, chrome plating, carbon thin films, and/or diamond-like carbon coatings.

Thehousing14 may allow for the placement of a cap after implantation to protect the pieces inside or to create a smoother surface. Examples are shown inFIGS. 40-43.

FIGS. 40 and 41 illustrate ahousing2114 with a flange2132. A smooth, convex-curved cap2133 includes aninternal recess2134 closely matched to the exterior shape of the flange2132 so that thecap2133 can engage the flange2132 in a snap-fit relationship.

FIGS. 42 and 43 illustrate ahousing2214 with aflange2232 andinternal threads2233. Acap2234 with a smooth, convex-curved exterior includes acentral stud2235 with external threads2236 that can engageinternal threads2233 to secure thecap2234 to thehousing2214.

Referring back toFIGS. 3 and 4, thecollet16 is a hollow member with first and second ends67,68 and anexterior surface70. Thecollet16 has acentral bore72 which is sized to receive thetensile member10 described above. For example, thecentral bore72 may be cylindrical, with a diameter “D4” which is initially slightly larger than a diameter D1 of thetensile member10. Thecentral bore72 need not have a circular cross-section; the cross-section may be a polygon shape (e.g. triangular, square) or it may be a lobed shape (e.g., triangular with radiused corners) or spline shaped.

Thecollet16 is configured so as to readily permit it to be swaged, i.e. shaped in such a manner to reduce its cross-section and the size of thecentral bore72 so that it firmly engages thetensile member10 and allows a tensile force to be applied thereto. The act of swaging may involve thecollet16 being deformed, crushed, collapsed, or compressed. Thecollet16 is configured, e.g., sized and shaped, such that when subjected to pressure from thesleeve18, it will abut theinternal flange31 of thebody20, thus stopping its further axial movement, and permitting the swaging action (described in more detail below) to take place without axial movement of thecollet16 relative to thetensile member10 orhousing14.

Theexterior surface70 has a shape adapted to interact with the interior surface of thesleeve18 described below so as to produce a radially inwardly directed force on thecollet16 in response to the axial movement of thesleeve18. Fundamentally, at least one of theexterior surface70 of thecollet16 and the interior surface of thesleeve18 incorporates a taper i.e., a diameter or lateral dimension which is larger near the first end and smaller near the second end of the respective element. In the example shown inFIGS. 3 and 4, theexterior surface70 is cylindrical with chamfered ends.FIGS. 21-26 generally show alternative collets where the peripheral exterior surface is tapered, defining a shape like a frustum of a cone.

Additionally, theinternal flange31 of thehousing14 and theexterior surface70 may be configured such that axial movement of thecollet16 towards thefirst end22 causes a radially inwardly directed force on thecollet16. For example,FIG. 4 illustrates atransition section31′ adjacent the interface of theinternal flange31 in the cylindrical portion of theinterior surface28. The shaping of thistransition section31′ may be tailored to control the direction and magnitude of a radially-inward force applied to thecollet16. In general, the transition section defines a constriction adjacent theinternal flange31. In the illustrated example, thetransition section31′ is a straight taper or generally conical section; other shapes such as chamfers, fillets, curves, splines, etc. may be used.

Thecollet16 may be made from any material which will engage thetensile member10 so as to transfer tensile force thereto and which can be successfully swaged. Nonlimiting examples of suitable materials include polymers and metal alloys. One nonlimiting example of a suitable metal alloy is an aluminum alloy. Thecollet16 may be fabricated by a technique such as machining, forging, casting, sintering, or additive manufacturing (e.g., “3D printing”). Thecollet16 may be made from a material which has a lower effective elastic modulus than thesleeve18, or stated another way, is “softer” than thesleeve18. Optionally, thecollet16 may comprise a porous material.

Optionally, thecollet16 may be coated with a low-friction coating such as diamond-like carbon (“DLC”).

Optionally, thecollet16 may incorporate a geometry having sections of removed material or “negative space” which is configured to facilitate collapse of thecollet16, so as to optimize stress around thetensile member10. Examples of collapsing geometries are illustrated inFIGS. 21-26.

FIGS. 21 and 22 show acollet116 having a longitudinal throughslot74 formed on one side, and alongitudinal groove76 formed opposite the throughslot74.

FIGS. 23 and 24 show acollet216 having a plurality ofcurvilinear openings77 formed through the wall thereof, providing a negative space that allows thecollet216 to collapse inwards.

FIGS. 25 and 26 show acollet316 having a plurality of longitudinal throughslots78 formed in the wall thereof, eachslot78 being open to at least one end and extending less than the full length of thecollet316. The throughslots78 are arranged to define a spring-like structure.

Optionally, thecollet16 may incorporate a geometry having sections of removed material or “negative space” which are configured to facilitate collapse of thecollet16, in such a way that portions of the collet protrude inward into the central bore to provide improved engagement with atensile member10. Examples of collapsing geometries are illustrated inFIGS. 80-85.

FIGS. 80-82 show acollet3716 having asidewall3718 defining acentral bore3720. It may be made from sintered powdered metal alloy or another material with similar swaging characteristics. Thecentral bore3720 may include asurface texture3721 such as the illustrated threads which serve to enhance grip on a tensile member10 (not shown inFIG. 82). An array oflongitudinal grooves3722 having a U-shape are formed in the outer surface of thesidewall3718. Each of thegrooves3722 defines a thin neck3724 (seeFIG. 82).

The example shown inFIGS. 80-82 is generally cylindrical prior to swaging.FIGS. 83-85 show thecollet3716 after swaging. Post-swaging, thegrooves3722 may be tapered, having a maximum width at a distal end of thecollet3716, and tapering away to a negligible dimension near a middle portion of thecollet3716. When swaged as described herein, thesidewall3718 tends to collapse in a manner such that the neck3824 folds into a U-shape and protrudes into the central bore3720 (seeFIG. 85), forming aprotrusion3726 which may have a shape similar to a Roman arch.

Referring back toFIGS. 3 and 4, thesleeve18 is a hollow member with open first and second ends80,82 Thesleeve18 is sized is such that thetensile member10 described above can pass through the first and second ends80,82. Thesleeve18 is defined by aperipheral wall84 having interior andexterior surfaces86,88, respectively. In the illustrated example, thesleeve18 is generally cylindrical in shape.

Theinterior surface86 has a shape adapted to interact with theexterior surface70 of thecollet16 described above so as to produce a radially inwardly directed force on thecollet16 in response to the axial movement of thesleeve18. As noted above, at least one of theexterior surface70 of thecollet16 and theinterior surface86 of thesleeve18 incorporates a taper i.e., a diameter or lateral dimension which is larger near the first end and smaller near the second end of the respective element. In the example shown inFIGS. 3 and 4, theinterior surface86 is tapered, defining a shape like a frustum of a cone, with a larger diameter at thefirst end80.

Theinterior surface86 of thesleeve18 may have various geometries selected to optimize the swaging force. Theinterior surface86 of thesleeve18 shown inFIG. 4 has a one-way taper. Examples of alternative compression surface geometries are illustrated inFIGS. 27-29.

FIG. 27 shows aninterior surface186 with a two-way taper.

FIG. 28 shows aninterior surface286 having a series of step-like faces defining a “scaled” geometry.

FIG. 29 shows aninternal surface386 with an integral snap ring geometry.

Thesleeve18 may incorporate a retention feature which cooperates with the sleeve retention feature of the housing described above in order to retain thesleeve18 in an activated position.FIG. 4 illustrates an exemplary retention feature in the form of anannular step90 formed in theexterior surface88 of thesleeve18.

Thesleeve18 may be made from any material which is biocompatible and which can receive axial force and transfer radial compressive force to thecollet16. Nonlimiting examples of suitable materials include polymers and metal alloys. One nonlimiting example of a suitable metal alloy is a stainless steel alloy. Thesleeve18 may be fabricated by a technique such as machining, forging, casting, sintering, or additive manufacturing (e.g., “3D printing”). Optionally, thesleeve18 may comprise a porous material.

All or a portion of thesleeve18 may be provided with a known coating such as titanium nitride, chrome plating, carbon thin films, and/or diamond-like carbon coatings.

FIGS. 30-37 illustrate another exemplary embodiment of an anchor, denoted2012 generally. Theanchor2012 is generally similar in construction to theanchor12 described above. Any elements of theanchor2012 not specifically described may be taken to be identical to those of theanchor12. Referring toFIGS. 30 and 31, theanchor2012 includes ahousing2014, acollet2016 received in thehousing2014, and asleeve2018 received in thehousing2014 which is capable of moving axially within thehousing2014 so as to swage thecollet2016, thus retaining thetensile member10.

Thehousing2014 has abody2020 extending along a central axis “A” between first andsecond ends2022,2024. Thebody2020 is defined by a peripheral wall2026 having interior andexterior surfaces2028,2030 respectively, and defining ahollow interior2029. In the illustrated example, thebody2020 is generally cylindrical in shape. The first end of thebody2022 has aninternal flange2031 which is sized to define a stop against axial motion of thecollet2016.

A generallyannular flange2032 is located at or near thesecond end2024 and extends radially outwards from thebody2020. In the example illustrated inFIGS. 30 and 31, theflange2032 incorporates chamferedsurfaces2037 which are configured to engage jaws of an insertion instrument is described in more detail below.

Theexterior surface2030 of thehousing2014 may be configured to improve the connection between thehousing2014 and the bone. Examples of exterior surfaces configured to achieve this function are described above and illustrated inFIGS. 6, 7, and 8.

Thehousing2014 may incorporate a connection feature configured to permit a secure, releasable connection to an instrument used for insertion or manipulation of theanchor2012. Examples of connection features are described above and illustrated inFIGS. 9-17.

Thehousing2014 may incorporate a sleeve retention feature configured to retain thesleeve2018 in an activated position. These features interact with retention features of thesleeve2018 which are described in more detail below. In the illustrated example, the retention feature is a dimension (e.g., diameter) “D6” of theinterior surface2028 which is selected to provide a predetermined fit with thesleeve2018, as described in more detail below.

Thecollet2016 is a hollow member with first andsecond ends2067,2068 and anexterior surface2070. Thecollet2016 has acentral bore2072 which is sized to receive thetensile member10 described above. For example, thecentral bore72 may be cylindrical, with a diameter “D5” which is initially slightly larger than a diameter D1 of thetensile member10. Thecentral bore2072 need not have a circular cross-section; the cross-section may be a polygon shape (e.g. triangular, square) or it may be a lobed shape (e.g., triangular with radiused corners).

Thecollet2016 is configured so as to readily permit it to be swaged, i.e. shaped in such a manner to reduce its cross-section and the size of thecentral bore2072 so that it firmly engages thetensile member10 and allows a tensile force to be applied thereto. The act of swaging may involve thecollet2016 being deformed, crushed, collapsed, or compressed. Thecollet2016 is configured, e.g., sized and shaped, such that when subjected to pressure from thesleeve2018, it will abut theinternal flange2031 of thebody2020, thus stopping its further axial movement, and permitting the swaging action to take place without axial movement of thecollet2016 relative to thetensile member10 orhousing2014.

Theexterior surface2070 has a shape adapted to interact with the interior surface of thesleeve2018 described below so as to produce a radially inwardly directed force on thecollet2016 in response to the axial movement of thesleeve2018. Fundamentally, at least one of theexterior surface2070 of thecollet2016 and the interior surface of thesleeve2018 incorporates a taper i.e., a diameter or lateral dimension which is larger near one end and smaller near the opposite end of the respective element. In the example shown inFIGS. 30 and 31, theexterior surface2070 is cylindrical with chamfered ends. The exterior dimensions and shape of theexterior surface2070 are selected so as to provide a predetermined fit with thesleeve2018 both before and after a compression process, as described in more detail below.

Additionally, theinternal flange2031 of thehousing2014 and theexterior surface2070 may be configured such that axial movement of thecollet2016 towards thefirst end2022 causes a radially inwardly directed force on thecollet16. Examples of this configuration are described above.

Thesleeve2018 is a hollow member with open first andsecond ends2080,2082. Thesleeve2018 is sized is such that thetensile member10 described above can pass through the first andsecond ends2080,2082. Thesleeve2018 is defined by aperipheral wall2084 having interior andexterior surfaces2086,2088, respectively. In the illustrated example, theexterior surface2088 of thesleeve2018 is generally cylindrical in shape.

Theinterior surface2086 has a shape adapted to interact with theexterior surface2070 of thecollet2016 described above so as to produce a radially inwardly directed force on thecollet2016 in response to the axial movement of thesleeve2018. As noted above, at least one of theexterior surface2070 of thecollet2016 and theinterior surface2086 of thesleeve2018 incorporates a taper i.e., a diameter or lateral dimension which is larger near one end and smaller near the opposite end of the respective element. In the example shown inFIGS. 30 and 31, theinterior surface2086 is tapered, defining a shape like a frustum of a cone, with a larger diameter at thefirst end2080.

Theinterior surface2086 of thesleeve2018 may have any of the various geometries described above which are selected to optimize the swaging force.

Thesleeve18 may incorporate a retention feature which cooperates with the sleeve retention feature of the housing described above in order to retain thesleeve18 in an activated position. In the illustrated example, the retention feature is a dimension (e.g., diameter) “D7” of theexterior surface2088 which is selected to provide a predetermined fit with thesleeve2018 both before and after a compression process, as described in more detail below.

FIGS. 34-37 illustrate the engineered interference lock feature of theanchor2012. Referring toFIGS. 34 and 35, in the assembled, but uncompressed condition, there is a small clearance between the inside diameter D6 of thehousing2014 and the outside diameter D7 of thesleeve2018. There is also a small clearance between the inside diameter D5 of thecollet2016 and the outside diameter D1 of thetensile member10.

FIGS. 36 and 37 illustrate theanchor2012 in the compressed or actuated condition (e.g. after being compressed by one of the insertion instruments described herein). There is a predetermined interference fit between the inside diameter D6 of thehousing2014 and the outside diameter D7 of thesleeve2018. This occurs because thesleeve2018 is forced radially outwards as it is pushed axially over thecollet2016. Furthermore, there is a predetermined interference fit between the inside diameter D5 of thecollet2016 and the outside diameter D1 of thetensile member10. In this compressed condition, thetensile member10 is significantly compressed radially and held by the housing-sleeve-collet concentrically compressed configuration.

The materials and/or coatings used in the construction of thehousing2014,collet2016, andsleeve2018 may be as described for thehousing14,collet16, andsleeve18 described above.

FIGS. 72-76 illustrate another exemplary embodiment of an anchor, denoted3012 generally, which incorporates a “breakaway” or “snap-off” connection. Theanchor3012 is generally similar in construction to theanchor2012 described above. Any elements and/or features of theanchor2012 not specifically described may be taken to be identical to those of theanchor2012. Referring to FIGS. #, theanchor3012 includes ahousing3014, acollet3016 received in thehousing3014, and asleeve3018 received in thehousing3014 which is capable of moving axially within thehousing3014 so as to swage thecollet3016, thus retaining thetensile member10.

Thehousing3014 has abody portion3020 extending along a central axis “A′” between first andsecond ends3022,3024. Theportion3020 is defined by aperipheral wall3026 having opposed interior and exterior surfaces, and defining a hollow interior. In the illustrated example, thebody portion3020 is generally cylindrical in shape. The first end of thebody3022 has aninternal flange3031 which is sized to define a stop against axial motion of thecollet3016.

A generallyannular flange3032 is located at or near thesecond end2024 and extends radially outwards from thebody2020.

Thehousing3014 includes anextension portion3021 extending away from thesecond end2024 of thebody portion3020. Theextension portion3021 is coupled to thebody portion3020 by abreakaway structure3023. As manufactured and prior to use, theentire housing3014 forms a single unitary, integral, or monolithic structure including thebody portion3020,extension portion3021, andbreakaway structure3023.

Theextension portion3021 extends between afirst end3025 and a second3027. Thesecond end3027 is interconnected to thebreakaway structure3023. Thefirst end3025 may be provided with a connector for being connected to an insertion instrument which is described in more detail below. In the illustrated example (FIG. 74) thefirst end3025 is provided with aconnector3029 in the form of screw threads.

Thebreakaway structure3023 is configured in terms of its shape, dimensions, and material properties such that it will retain its structural integrity and interconnected thebody portion3020 and theextension portion3021 when subjected to tensile loads up to a first magnitude sufficient to complete a swaging process of theanchor3012 as described elsewhere herein. This is referred to herein as a “first predetermined tensile load”. Thebreakaway structure3023 is further configured in terms of its shape, dimensions, and material properties such that it will fail and permit separation of thebody portion3020 and theextension portion3021 when subjected to tensile loads equal to or greater than a second magnitude, referred to herein as a “second predetermined tensile load”. The second tensile load is greater than the first tensile load. The second tensile load may be selected to be sufficiently greater than the first predetermined tensile load such that failure of thebreakaway structure3023 is unlikely to occur during the swaging process. Stated another way, the second predetermined tensile load may have a safety margin over the first predetermined tensile load. In one example, the second predetermined tensile load may be selected to be at least 50% to 100% greater than the first predetermined tensile load.

In general, thebreakaway structure3023 may include one or more stress-concentrating columns which present a known cross-sectional area, thus permitting reliable computation of the tensile stresses in thebreakaway structure3023 for a given applied load.

In the illustrated example, best seen inFIGS. 75 and 76, thebreakaway structure3023 includes a plurality of stress-concentratingcolumns3024 arrayed around the periphery of theflange3032, which have a circular cross-sectional shape adjacent to and/or or at theflange3032. The stress-concentratingcolumns3024 are separated byopenings3069. It will be understood that other column cross-sectional shapes providing a predictable cross-sectional area may be used, and that the cross-sectional shape may vary over the length of the column.

Optionally, the stress-concentratingcolumns3024 may intersect theflange3032 at the bottom ofrecesses3033 formed in theflange3032. In use, this permits the stress-concentratingcolumns3024 to separate along the fracture plane which is “below” atop surface3035, or stated another way it is sub-flush to, or recessed from, thetop surface3035.

The exterior surface of thehousing2014 may be configured to improve the connection between thehousing2014 and the bone. Examples of exterior surfaces configured to achieve this function are described above and illustrated inFIGS. 6, 7, and 8.

Thehousing3014 andsleeve3018 may incorporate mutual retention feature configured to retain thesleeve3018 in an activated position, as described above with respect toanchor2012.

Thecollet3016 is a hollow member. Thecollet2016 has acentral bore2072 which is sized to receive thetensile member10 described above. In one example, thecollet3016 may incorporate substantially the same features ascollet2016 described above.

Thesleeve3018 is a hollow member in one example, thesleeve3018 may incorporate substantially the same features assleeve2018 described above.

All or a portion of the anchors described above may be made as part of an integral, unitary, or monolithic whole. This may be accomplished, example, by using additive manufacturing process.

FIG. 38 illustrates anexemplary anchor1312 comprising ahousing1314, acollet1316, and asleeve1318 corresponding to those components as described above. In this example, thecollet1316 is integral, unitary, or monolithic with theanchor1312. Thesleeve1318 is a separate component.

FIG. 39 illustrates anexemplary anchor1412 comprising a housing1414 which receives aninternal member1416. Theinternal member1416 is integral, unitary, or monolithic with theanchor1412. Thisinternal member1416 is shaped like a tapered coil spring. The bottom end of thecoil spring1416 is held stationary while the top of thecoil spring1416 is allowed to rotate by means of a rotary actuator tool (not shown) that holds thehousing1412 stationary. This tool could be similar to a spanner-type device with pins or lugs and holds thehousing1412 stationary by interfacing with the four locking recesses cut into the flange as shown. When the top of theinternal member1416 is rotated (in this case clockwise), the inner diameter is gradually reduced and constricts around thetensile member10 to hold it in place axially.

FIG. 68 illustrates anexemplary anchor2712 comprising ahousing2714 which receives aninternal member2716. Thisinternal member2716 is shaped like an accordion or wave spring. When compressed axially, the folds deform, bind together, and swage down on thetensile member10 radially inward.Internal member2716 thus functions as both a collet and a sleeve. Theinternal member2716 optionally may be integral, unitary, or monolithic with theanchor2712.

FIGS. 44 and 45 anexemplary insertion instrument1500 which may be used to insert, tension, and activate theanchors12 described above. The basic components of theinsertion instrument1500 are abody1502 having a handle, astem1504 extending from thebody1502 and having ananchor connection mechanism1508 disposed at a distal end thereof, ahollow pushrod1510 extending through thestem1504 and slidably movable between retracted and extended positions, and adriving mechanism1512 for moving thepushrod1510 between retracted and extended positions. Thestem1504 and thepushrod1510 may be rigid or flexible.

In the illustrated example, thedriving mechanism1512 comprises atoggle linkage1516 which is manually operated by anoperating handle1514. More specifically, thetoggle linkage1516 is arranged such that when theoperating handle1514 is released, return springs1518 drive theoperating handle1514,toggle linkage1518, andpushrod1510 towards the retracted position, and when theoperating handle1514 is squeezed, it moves thetoggle linkage1516 which in turn extends thepushrod1510 towards the extended position. Thetoggle linkage1516 may be arranged to have a fixed or adjustable range of motion.

It will be understood that thedriving mechanism1512 could be replaced with a different type of mechanical linkage or with the powered devices such as an electrical, pneumatic, or hydraulic actuator (not shown).

FIG. 46 illustrates anexemplary tensioner1520 having ahousing1522 which may be connected to theinsertion instrument1500. Thetensioner1522 includes ayoke1524 configured to clamp atensile member10 passing through thepushrod1510. Theyoke1524 is movable relative to thehousing1522, for example using an internal mechanical driving mechanism (not shown) actuated by anoperating knob1526. Means may be provided for measuring the tension applied to thetensile member10. For example, theyoke1524 may be connected to thehousing1522 through a calibrated spring such that the deflection of theyoke1524 is proportional to applied tension. Alternatively, a calibrated force gauge or other similar mechanism (not shown) may be provided.

Thetensioner1520 ofFIG. 46 is effective to set the tension on a singletensile member10. In various applications, which will be described in more detail below, it is desirable to pass multipletensile members10 through a single anchor, and to set the tension of each of thetensile members10 independently.

FIG. 86 illustrates anexemplary multi-strand tensioner3920 having ahousing3922 which may be connected to the any of the insertion instruments described herein. Thehousing3922 includes first and second sub-housings3924 Which are arranged in a diverging Y-shape. Each sub-housing3924 includes ayoke3926 configured to clamp atensile member10 passing through the pushrod of the insertion instrument. Eachyoke3926 is movable relative to its respective sub-housing3924, for example using an internal mechanical driving mechanism (not shown) actuated by anoperating knob3928. Means may be provided for measuring the tension applied to thetensile member10. For example, theyoke3926 may be connected to the respective sub-housing3924 through a calibrated spring such that the deflection of theyoke3926 is proportional to applied tension. Alternatively, a calibrated force gauge or other similar mechanism (not shown) may be provided.

FIG. 87 illustrates another example of amulti-strand tensioner3930 including ahousing3932 including first and second sub-housings3934 arranged in a coaxial configuration. Each sub-housing3934 includes ayoke3936 configured to clamp atensile member10 passing through the pushrod of the insertion instrument. Eachyoke3936 is movable relative to its respective sub-housing3934, for example using an internal mechanical driving mechanism (not shown) actuated by anoperating knob3938. Means may be provided for measuring the tension applied to thetensile member10. For example, theyoke3936 may be connected to the respective sub-housing3934 through a calibrated spring such that the deflection of theyoke3936 is proportional to applied tension. Alternatively, a calibrated force gauge or other similar mechanism (not shown) may be provided.

An exemplary configuration of thestem1504 andpushrod1510 are shown in more detail inFIGS. 47 and 48.

The distal end of thestem1504 incorporates means for engaging and holding ananchor12. In the illustrated example, thestem1504 includes a pair ofopposed jaws1528 withtips1530, which may be formed as integral, spring-like extensions of thestem1504. Thetips1530 may be formed with lateral andaxial engagement surfaces1532,1534 respectively, in order to engage lateral and axial faces,33,35 respectively of the anchor12 (shown schematically inFIG. 47). Thejaws1528 are provided with axially-extendinghooks1536 which are set back from thetips1530. Aclip1538 having a U-shape with axially-extendinglegs1540 is disposed laterally between the jaws, in an axial position which is between thetips1530 and thehooks1536. Theclip1538 may have an opening1542 passing therethrough, and thepushrod1510 may be stepped, having a first portion at its distal end small enough to pass through the opening1542, and a second portion sufficiently larger to engage theclip1538.

FIG. 47 shows thestem1504 with thepushrod1510 in a fully extended position, pushing theclip1538 outwards and spreading thejaws1528 apart so as to release theanchor12.FIG. 48 shows thestem1504 with thepushrod1510 in a retracted position, allowing theclip1538 to move inwards, engaging thehooks1536, thereby pulling the jaws inwards so thetips1530 engage theflange32 of theanchor12. In this position, theanchor12 is securely held by thestem1504 and may be manipulated as necessary. Theclip1538 secures thejaws1528 in the closed position until such time as thepushrod1510 is actuated, thus disengaging the clip in the jaws as shown inFIG. 33.

FIGS. 49-52 show the sequence of operation of theinsertion instrument1500.FIG. 49 shows ananchor12 received in thejaws1528, with theclip1538 is in a released position.FIG. 50 shows theclip1538 in an engaged position, holding thejaws1528 closed. Theclip1538 may be engaged manually, or may be pressed against a tool or fixture (not shown) in order to engage it.FIG. 51 shows thepushrod1510 being actuated to press thesleeve18 down over thecollet16.FIG. 52 shows theclip1538 moved to the released position by thepushrod1510, and thejaws1528 open so that the insertion instrument can be removed.

FIGS. 53-58 illustrate analternative stem2504 and a method of its operation. The distal end of thestem2504 includes pair ofopposed jaws2528 withtips2530, which may be formed as integral, spring-like extensions of thestem2504. Thejaws2528 flank apushrod2510 substantially similar topushrod1510 described above. Thetips1530 may be formed with V-shapedengagement surfaces2532 in order to engage ananchor12. The V-shapedengagement surfaces2532 are especially suitable for engaging thechamfered surfaces2037 of theflange2032 of theanchor2012. A generallytubular lock sleeve2538 havingconical end face2540 surrounds thestem2504.

FIGS. 53-58 show the sequence of operation of thealternative stem2504.FIG. 53 shows thelock sleeve2538 retracted from thejaws2528. Ananchor2012 is ready to be picked up by thejaws2538. Theanchor2012 may be held in this position by suitable packaging (not shown).

FIG. 54 shows thejaws2538 sprung over top of and lightly engaging theflange2032 of theanchor2012 with spring pressure.

FIG. 55 shows thelock sleeve2538 axially slid over thejaws2538, applying radially inward compressive pressure to the jaws and securely retaining theanchor2012.

FIGS. 56-57 shows successive stages of actuation of the pushrod to crimp atensile member10 in theanchor2012, substantially as described above.

Three.58 shows thelock sleeve2538 retracted from thejaws2538, allowing thestem2504 two be detached from theanchor2012.

FIG. 59 illustrates anotheralternative stem1604. It includesmale threads1646 formed on a distal end which engage female threads formed onanchor housing14. It also includes an axially-facingshoulder1648. When fully threaded onto thestem1604, theflange32 of thehousing14 abuts theshoulder1646. This construction provides a highly rigid interconnection between thehousing14 and thestem1604 in order to maximize the surgeon's control and ability to manipulate theanchor12. The hollow pushrod1610 is mounted inside the stem and operates like thepushrod1510 described above in order to swage thecollet16 when desired.

FIGS. 74 and 77-79 illustrate anotheralternative insertion instrument3500 which may be used to insert, tension, and activate theanchors12 described above. Theinsertion instrument3500 is particularly suitable for use with the breakaway or snap-offanchor3012 as shown inFIGS. 72-76. The basic components of theinsertion instrument3500 are abody3502 having a handle, ahollow pushrod3510 extending through thebody3502 and slidably movable between retracted and extended positions, and adriving mechanism3512 for moving thepushrod3510 between retracted and extended positions. Thebody3502 may include aconnector3504 complementary to aconnector3029 of theanchor3012. In the illustrated example, thebody3502 is provided with aconnector3504 in the form of screw threads.

The operation of theinsertion instrument3502 to implantanchor3012 may be better understood with reference toFIG. 77-79. As shown inFIG. 77, theanchor3012 may be coupled to theinstrument3500 using theirmutual connectors3029,3504. Thepushrod3510 initially rests against an end surface of thesleeve3018 with essentially no load applied. Atensile member10 passes through thecollet3016, thesleeve3018, and thehollow pushrod3510.

Prior to any swaging operation, thetensile member10 may be tensioned using methods described elsewhere herein. Once desired tension has been established, theinstrument3500 is actuated. More specifically, thepushrod3510 extends outward from thebody3502. This applies a compressive load to thesleeve3018, causing it to interact with thebody portion3020,collet3016, or both in order to swage thecollet3016 around thetensile member10, thus retaining thetensile member10 in-place with the desired amount of tension. As the swage cycle is completed, ashoulder3511 of thepushrod3510 makes physical contact with theflange3032 of thehousing3014.

Will be understood that theextension housing3021 is mechanically coupled to thebody3502 of theinstrument3500. Accordingly, extension of thepushrod3510 results in a tensile load being applied to thebreakaway structure3023 described above. This load is transferred through some combination of friction between thesleeve3018 and/or physical contact between theshoulder3511 in theflange3032. As described above, the step of swaging is accomplished using a first predetermined tensile load.

Once the swaging procedure is completed, thepushrod3510 is further actuated as shown inFIG. 79 to apply a tensile load sufficient to fracture thebreakaway structure3023 and separate thehousing body portion3020 from theextension portion3021. This is accomplished using a second predetermined tensile force greater than the first predetermined tensile load. Once accomplished, theinstrument3500 with thehousing extension portion3021 still attached may be withdrawn, leaving theanchor3012 in-place with thetensile member10 secured with the desired amount of tension. Any remaining portion of thebreakaway structure3023 is below flush from theouter surface3035 of theflange3032. It thus does not protrude to irritate or injure the patient or the surgeon, and no additional training operation is required.

FIG. 60 illustrates analternative insertion instrument2300. It includes astem2304 extending from thebody2302 and having ananchor connection mechanism2308 disposed at a distal end thereof. Thestem2304 may be flexible as a result of its material selection. Alternatively, it may incorporate linked segments, corrugations, or similar structures to provide flexibility. A hollow pushrod (not visible), which may be flexible, extends through the interior of thestem2304 and is slidably movable between retracted and extended positions. The hollow pushrod operates like thepushrod1510 described above in order to swage thecollet16 when desired.

Other anchoring devices may be used in conjunction with the various embodiments ofanchors12 described above in order to implant atensile member10.FIGS. 62-65, 95, and 96 illustrate examples of various anchoring devices.FIG. 62 illustrates a “button”1600 to which a tensile member may be tied.FIG. 63 illustrates a screw-insuture anchor1602.FIG. 64 illustrates aplate1605 having a series of openings formed therein, each of which may receive an anchor.FIG. 65 illustrates agrommet1606 which has a smooth interior surface to allow a tensile member to pass freely therethrough.FIG. 95 illustrates another type of button orwasher1608 through which a tensile member may be tied or passed. Thebutton1608 includes aU-shaped slot1611 as well as ahole1613 which can accept a pin or wire to further increase stability and fixation.FIG. 96 illustrates another type of button orwasher1614 through which a tensile member may be tied or passed. Thewasher1614 is generally racetrack-shaped in plan view and includes two opposedU-shaped slots1616. The portion of thewasher1614 between the 2slots1616 may incorporate tapered sides giving it a “dog-bone” shape.

The method of applying these principles for implantation and tensioning of atensile member10 will now be described in more detail with reference toFIGS. 2 and 66. This particular example illustrates the use of atensile member10 to stabilize a human femur. It will be understood that this is merely an example, and that the apparatus and methods described herein may be used to secure and tension a tensile member in any application.

Initially, atensile member10 is provided. An appropriate route through bone “B” or other tissue is determined, and apassage1700 having first andsecond ends1702,1704 is drilled in the bone B. Thesecond end1704 of thepassage1700 is prepared to receive theanchor12, for example by drilling an appropriately-sized bore1706 communicating with thepassage1700.

Afirst end11 of thetensile member10 is secured in the first end of thepassage1700. This may be done using theanchor12 as described above, or some other type of anchor. In the illustrated example, thefirst end11 of the tensile member is secured to abutton1600 as described above. Thetensile member10 is threaded through thepassage1700 so that itssecond end13 extends from thesecond end1704 of thepassage1700.

Ananchor12 according to one of the embodiments described above is loaded into theinstallation instrument1500 described above or another appropriate instrument. Thesecond end13 of thetensile member10 is threaded through theanchor12 and theinstallation instrument1500 and optionally through thetensioner1520.

Theinstallation instrument1500 is then used to seat to theanchor12 into thebore1706 formed in the bone B. The seating process may include methods such as simple axial driving, an adhesive bond, threading, screwing into the bone B with small screws through the flange, or counter-sinking into the bone surface.

With theanchor12 seated, but thecollet16 not yet swaged, tension may be applied to thetensile member10, for example using thetensioner1520 described above. This is referred to as “provisional tensioning”.

The properties of theanchor12 and theinstallation instrument1500 enables provisional and permanently stable tensioning of thetensile member10, and allows the surgeon to load-cycle and re-tension thetensile member10 before setting final tension. More specifically, With theinsertion instrument1500 abutted against theflange32 of theanchor12, tension can be added and removed. The ligament or joint being repaired can be load cycled by moving it through some or all of its range of motion before setting final tension.

In addition to producing more accurate and repeatable suture tensions, provisional tensioning with a load-setting/load-reading instrument (especially when the suture crosses the axis of a joint, such as a medial collateral ligament (MCL) repair technique) allows the surgeon to visualize the increase/decrease in tension throughout the joint range of motion (max flexion to max extension). This allows the surgeon to ensure that the tension stays within an acceptable range—and this check is done after load cycling the ligament in question to ensure the settle-in period is complete.

Once the surgeon is satisfied with the tension established, theinsertion instrument1500 may be activated. Thedriving mechanism1512 is used to force thepushrod1510 towards the actuated position. This drives thesleeve18 down over thecollet16, thus swaging thecollet16 around thesecond end13 of thetensile member10. This swaging action takes place with thecollet16 bottomed out at thefirst end22 of thehousing14 of theanchor12. Accordingly, the act of swaging causes little to no change in the tension applied to thetensile member10.

As thesleeve18 reaches the fully-actuated position, the sleeve retention features of thehousing14 and thesleeve18 become mutually engaged.FIG. 2 shows an example in which thelocking tabs66 of thehousing14 engage theannular step90 of thesleeve18. This prevents retraction of thesleeve18 and sets thetensile member10 permanently in position, with the predetermined amount of tension. Thetensile member10 is thus secured to the bone B with a desired tension.

For any of the anchors and any of the procedures described herein, it may be desirable to cut off thetensile member10 so that it does not protrude beyond the anchor once the swaging operation is completed. This avoids injury or irritation to the patient.

FIGS. 88-93 illustrate exemplary cutters which may be used to sever thetensile member10 at a below-flush location relative to the anchor.

For example, referring toFIG. 88, acutting instrument4000 may include abody4002 with the plurality of collapsible,tapered jaws4004 which have aconvex nose4006. These are shaped so as to protrude into arecess4008 which may be formed in thehousing14 of theanchor12, or alternatively in the housing of any of the anchors described herein.

FIG. 89 shows thecutting instrument4000 in use, where atensile member10 has been passed through theanchor12 and secured in place with thecollet16 and swaged18. Thecollapsible jaws4004 are in an extended position in which they slide over thetensile member10 and allow thenose4006 to fit into therecess4008.FIG. 90 shows acutting instrument4000 being actuated, with the collapsible tapered jaws being drawn into thebody4002, thus causing them to collapse inward and sever thetensile member10. It will be noted that the cuttingplane4010 of thejaws4004 is below flush of an outer surface of thehousing14.

As another example,FIG. 91 illustrates acutting instrument4012 including abody4014 with aconvex nose4016. Contained within theconvex nose4016 is a cylindrical orspherical jaw4018 having acentral bore4019 sized to slide over thecentral member10. Means (not shown) may be provided for rotating thejaw4018 relative to thebody4014.

FIG. 91 shows thecutting instrument4012 in position with thetensile member10 passed through thejaw4018 and theconvex nose4016 received in arecess4008 of ananchor housing14.FIG. 92 shows thecutting instrument4012 being actuated, with thejaw4018 being rotated, thus causing it to sever thetensile member10. As with thecutting instrument4000, it is noted that the cuttingplane4010 of thejaw4016 is below flush of an outer surface of thehouse14.

FIG. 93 shows anexemplary actuation mechanism4020 similar to theinstrument1500 described above, comprising ahandle4022 and a lever-actuatedmechanism4024 operable to operate thejaws4004 or4018 described above. Theactuation mechanism4020 may be coupled to thecutting instrument4000 or4012 with aneck4026 which is rigid or flexible.

The procedure described above with reference toFIG. 66 may be performed as a conventional or “open” procedure or in an arthroscopic procedure.FIG. 61 illustrates how thealternative insertion instrument2300 may further facilitate an arthroscopic procedure. Thestem2304 is shown as being flexed in a curved shape so that it can pass through a small closed incision “C” in the soft tissue “ST” surrounding the joint. The other steps in the procedure described above would be identical.

FIG. 69 illustrates an arthroscopic procedure in which a rigid stem is used to position the anchor in the pelvic region, close to the superficial surface of the skin.70 illustrates an arthroscopic procedure in which a rigid stem is used to position the anchor in the pelvic region, far from the superficial surface of the skin.70 illustrates an arthroscopic procedure in which a rigid stem is used to position the anchor in the knee region, close to the superficial surface of the skin.

As noted above, apparatus and methods described above may be used to implanttensile members10 for numerous different types of repairs and procedures. One specific example where the apparatus and methods are useful is to implant a tensile member in conjunction with a total knee replacement (TKR). This is referred to as a tension ligament augmentation (TLA) of the knee joint.FIG. 67 shows an example of a human knee joint comprising a portion of the “F” articulated with the tibia “T”. The knee joint has implanted therein an artificial joint “J”, the structure of which is outside the scope of the present invention.

Afirst passage1800 having first andsecond ends1802,1804 extends through the femur F. Asecond passage1900 having first andsecond ends1902,1904 extends through the tibia T. Thesecond end1904 of thesecond passage1900 is prepared to receive theanchor12.

Afirst end11 of thetensile member10 is secured in thefirst end1802 of thefirst passage1800 by an anchoring element such as abutton1600. Agrommet1606 is secured in thesecond end1804 of thefirst passage1800, and thetensile member10 passes through thegrommet1606.

Thetensile member10 further extends around the lateral aspect of the knee joint J down along the upper portion of the tibia T and into thefirst end1902 of thesecond passage1900. Thesecond end13 of thetensile member10 extends through the second passage, exiting at the second and1904 of thesecond passage1900.

Ananchor12 is described above is implanted in the second in1902 of thesecond passage1900. Thesecond end13 of thetensile member10 extends through theanchor12. Theanchor12 may be installed, and thetensile member10 may be tensioned and swaged in place using theinsertion tool1500 and methods substantially as described above.

One type of repair is a fracture repair. Examples of fracture repairs are shown inFIGS. 97-102.

FIG. 97 illustrates a pelvic brim fracture reduced with tension applied across the fracture site by means of atensile member10 is, extending through a passage formed in the bone and tensioned as described above, and secured at one end by an anchor (e.g. anchor12 as described above) and at the other end by a button (e.g. button1600 as shown inFIG. 62).

FIG. 98 shows a tibial epicondyle fracture reduced with tension applied transversely by means of severaltensile members10 extending through passages formed in the bone and tensioned as described above. One end of each tensile member is secured by an anchor (e.g.,anchor12 as described above), and the opposite ends of thetensile members10 are secured to a plate (e.g. plate1605 shown inFIG. 64).

FIG. 99 shows a fibular fracture reduced longitudinally with a nail and transversely by means of atensile member10 extending through a passage formed in the bone and tensioned as described above. One end of thetensile member10 is secured by an anchor (e.g.,anchor12 as described above), and the opposite end of thetensile member10 is secured to a button (e.g.,button1600 as shown inFIG. 62).

FIG. 100 shows a rotator cuff tensioned down against the proximal humorous by means of atensile member10 looped through the rotator cuff, with its distal ends tensioned as described above and secured by an anchor (e.g.,anchor12 as described above).

FIG. 101 shows a clavicle fracture reduced with tension applied along the longitudinal axis by means of atensile member10 extending through a passage formed in the bone and tensioned as described above. One end of thetensile member10 is secured by an anchor (e.g.,anchor12 as described above), and the opposite end of thetensile member10 is secured to a button (e.g.,button1600 as shown inFIG. 62).

FIG. 102 shows a for moral epicondyle fracture reduced attention applied transversely across by means of thetensile member10 extending through a passage formed in the bone and tensioned as described above. One end of thetensile member10 is secured by an anchor (e.g.,anchor12 as described above), and the opposite in thetensile member10 is secured to a button (e.g.,button1600 as shown inFIG. 62).

The apparatus and methods described above herein may further be used for various methods for augmenting or replacing natural ligaments. Some examples of ligament augmentations are described with reference toFIGS. 103-110. These augmentations have in common the use of one or moretensile members10 as described above having a first end anchored to a first bone, passing through a first passage in the first bone, spanning the gap to a second bone, spanning a second passage in the second bone, and having a second end anchored to the second bone.

In making these augmentations, thetensile members10 may be implanted, tensioned, and anchored using any of the apparatus and methods described above. In some of the exemplary augmentations, a singletensile member10 is used. This is referred to as a “single-strand” augmentation. It will be understood that a single strand of the tensile member may be made up of smaller individual fibers or sub-strands. In some of the exemplary augmentations, totensile members10 are used, where first ends of the two tensile members are anchored at a common first end point, and the twotensile members10 diverge such that their individual second ends are anchored at disparate endpoints. This is referred to as a “double-bundle” augmentation.

FIGS. 103A, 103B, and 103C show the human knee joint J having a single strand lateral cruciate ligament augmentation. A singletensile member10 has a first end anchored in the tibia T, passes through the tibia T and the fibula U, spans the gap across the lateral aspect of the tibia T and femur F, passes through the femur F, and has its second end anchored in the femur F.

FIGS. 104A, 104B, and 104C show the human knee joint J having a double bundle lateral cruciate ligament augmentation. A pair oftensile members10 has their common first ends anchored in the tibia T, passes through the tibia T and the fibula U, diverge as they span the gap across the lateral aspect of the tibia T and femur F, pass through the femur F through two separate channels, and have their individual second ends anchored in the femur F.

FIGS. 105A, 105B, and 105C show the human knee joint J, having a single strand medial cruciate ligament augmentation. A singletensile member10 has a first end anchored in the tibia T, passes through the tibia T, spans the gap across the medial aspect of the tibia T and femur F, passes through the femur F, and has its second end anchored in the femur F.

FIGS. 106A, 106B, and 106C show a human knee joint J, having a double bundle medial cruciate ligament augmentation. A pair oftensile members10 have their common first ends anchored in the tibia T, pass through the tibia T, diverge as they span the gap across the medial aspect of the tibia T and femur F, pass through the femur F through two separate channels, and have their individual second ends anchored in the femur F.

FIGS. 107A, 107B, and 107C show a human knee joint, having a double bundle anterior cruciate ligament augmentation. A pair oftensile members10 have their common first ends anchored in the tibia T, pass through the tibia T, diverge as they span the gap between the tibia T and femur F, pass through the femur F through two separate channels, and have their individual second ends anchored in the femur F.

FIGS. 108A, 108B, and 108C show a human knee joint, having a double bundle posterior cruciate ligament augmentation. A pair oftensile members10 have their common first ends anchored in the tibia T, pass through the tibia T, diverge as they span the gap between the tibia T and femur F, pass through the femur F through two separate channels, and have their individual second ends anchored in the femur F.

FIGS. 109A and 109B show a human foot having a double bundle ligament augmentation. A pair oftensile members10 have their common first ends anchored in the tibia T, pass through the tibia T, diverge as they exit the tibia and wrap around the calcaneus C, pass through the calcaneus C through two separate channels, and have their individual second ends anchored in the calcaneus C.

FIGS. 110A and 110B show a human foot having a double bundle ligament augmentation. A singletensile member10 has its first end anchored in the calcaneus C, spans the gap between the calcaneus and one of the metatarsals M, passes through the metatarsal M, and has its second end anchored in the metatarsal M.

For any of the ligament augmentations described above, and especially for the augmentations of the ligaments of the knee, it is desirable to correctly clock the insertion and origin of the suture passage to replicate the native stability of healthy knee ligament. For example,FIGS. 111A and 111B are schematic views of the medial aspect of the human knee joint, in extension and flexion, respectively, and having a double-bundle ligament augmentation including first and secondtensile members10,10′. It can be seen that the firsttensile member10 is under tension when the joint J is an extension, and the secondtensile member10 prime is under tension when the joint is in flexion. As another example,FIGS. 112A and 112B are schematic views of the medial aspect of the human knee joint, in extension and flexion, respectively and having a single-strand ligament augmentation. It can be seen that the singletensile member10 is under appropriate tension in both extension and flexion.

In order to determine accurate locations for drilling the bone passages to obtain the relationships described above, targets may be established on the epicondyle of the femur F or other bone structure. As shown inFIGS. 113 and 114, there would be atarget4050 for flexion augmentation and atarget4052 for an extension augmentation, both referenced relative to alandmark circle4054. Location of the targets may be expressed in Cartesian coordinates or in polar coordinates (R, THETA) as shown inFIG. 114.

The location of the targets may be established and transferred to the epicondyle or other bone by use of adrill guide4056 as seen inFIGS. 115-117. Thedrill guide4056 is a solid body having abackside4058 generally conformable to the epicondyle and afront side4060 provided withappropriate gradations4062 such as a Cartesian coordinate grid or polar coordinate grid. Thedrill guide4056 is configured to rotate with the movement of the knee joint J through various positions from full flexion to full extension and provides an accurate visual reference of a drill target. Thedrill guide4056 may be made of a freely-machine able material such as a biocompatible polymer, allowing the surgeon to drill through thedrill guide4056 into the bone.

Another type of repair that may be accommodated using the method and apparatus described herein as a “cerclage” in which atensile member10 is wrapped around a bone and then placed under tension to form a closed-loop structure.

FIGS. 118 and 119 illustrate anexemplary clamp4060 that may be used to receive and anchor distal ends of atensile member10. Theclamp4060 has abody4062 with open ends. Semi-cylindricalouter compression members4064 are disposed inside thebody4062, flanking aninner compression member4066. The inner andouter compression members4066 and4064 are mutually shaped to define two generally cylindrical channels, each of which receives an end of atensile member10. Theinner compression member4066 has acentral slot4068 which can receive alocking wedge4070. In use, the ends of thetensile member10 would be placed into the channels, the tensile member tensioned as described elsewhere herein, and then thelocking wedge4070 driven in to swaging compress thecompression members4064,4066, thus anchoring thetensile member10 and maintaining the desired tension.

FIGS. 120 and 121 illustrate anotherexemplary clamp4080 which may be used to receive an anchor distal ends of one or moretensile members10. Theclamp4080 includes ahousing4082, acollet4084, and asleeve4086. The characteristics and configuration of the elements of theclamp4080 may be substantially identical to corresponding elements of theanchor3012 described above, and theclamp4080 may be configured as a “breakaway” or “snap-off” device as described elsewhere herein. Theclamp4080 may include achannel4088 in thehousing4082 to allowtensile member10 to lie flat against it. Theclamp4080 may be implanted using any of the insertion instruments described herein.

FIG. 122 shows a cerclage applied to a human femur F using theclamp4080 ofFIGS. 120 and 121 in combination with atensile member10. Thetensile member10 is wrapped around the femur F or other bone, and is distal ends inserted through theclamp4080. The methods described above are used to tension the tensile member and to force thesleeve4086 down over thecollet4084 causing it to swage down onto and anchor thetensile member10.

In the process of performing any of the repairs and/or augmentations described herein, there is sometimes a need to ream out a passage in the existing canal of a human bone. During such reaming process, it is desirable to follow the past of least resistance and to cut away only soft bone, leaving the exterior wall undisturbed.

FIGS. 123-126 illustrate a self-trackingreamer4090 suitable for this purpose. Thereamer4090 includes ashaft4092 and ahead4094. Theshaft4092 is suitably sized and shaped to be received in a manual or power drill or similar device. Thehead4094 includesspiral flutes4096 terminating at acutting tip4098 having suitable cutting surfaces4100. Theflutes4096 may have a single or double lead. The shaft and head are made of a suitable material such as a stainless steel alloy and have dimensions selected so as to provide some flexibility in bending. Thehead4094 is configured have a greater diameter in itscentral portion4102 that at either itsproximate end4104 or thecutting tip4098. The overall shape may be described as a “cobra head” shape.

In use, thereamer4090 is effective to pull itself into and through the bone canal. Because of the increased diameter at thecentral portion4102, and the shape of thecutting tip4098 which principally cuts along the centerline, thereamer4090 is able to bend and follow the path of least resistance, cutting only soft bone and not the outer wall. Once thereamer4090 is driven to a desired distance, it can be driven backwards (e.g. counter-clockwise) to remove from the bone, or be pulled backwards with some force while driving clockwise to fully clear the bone canal.

The apparatus and method described herein has numerous benefits compared to the prior art. It provides a modular device and implant system and method that enables provisional and permanently stable tensioning of the tensile member, with minimally-invasive access to and limited visualization of the bone surface, using a device that is small and low-profile to prevent stress-shielding and soft tissue hang-up, implanted by simple and intuitive instrumentation that optimizes workflow and can be accomplished by one person.

The device and method described above may be used for procedures such as tensioning ligaments and tendons, augmenting ligaments and tendons, repairing and/or replacing ligaments and tendons, and reducing and fixate bone fractures.

The foregoing has described apparatus and methods for medical implants. All of the features disclosed in this specification, and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends, or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims (23)

What is claimed is:

1. A method for anchoring one or more tensile members to bone, comprising:

providing an anchor, including:

a housing extending along a central axis between open first and second ends, and having a hollow interior, the housing including a body portion and an extension portion interconnected by a breakaway structure which is configured to retain structural integrity under a first predetermined tensile load and to separate under a second predetermined tensile load which is greater than the first predetermined tensile load;

a collet disposed in the hollow interior of the body portion, the collet having a peripheral wall defining a central bore for accepting a tensile member therethrough and an exterior surface, wherein the collet is configured to be swaged around and against the tensile member;

a sleeve having a peripheral wall defining opposed interior and exterior surfaces, the sleeve disposed in the hollow interior of the housing and positioned generally axially adjacent to the collet, so as to be movable parallel to the central axis between first and second positions; and

wherein at least one of the exterior surface of the collet and the interior surface of the sleeve is tapered and the sleeve and the collet are arranged such that movement of the sleeve from the first position to the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around and against the tensile member;

passing one or more tensile members through the central bore of the collet;

seating the housing into a bore formed in the bone; and

driving the sleeve from the first position towards the second position under the first predetermined tensile load, so as to swage the collet around the one or more tensile members.

2. The method ofclaim 1 further comprising applying the second predetermined tensile load to the anchor such that the extension portion separates from the remainder of the housing.

3. The method ofclaim 2 wherein the breakaway structure separates along a fracture plane disposed below an exterior surface of the body portion.

4. The method ofclaim 1 further comprising applying tension to the one or more tensile members prior to driving the sleeve.

5. The method ofclaim 4 wherein the step of driving the sleeve causes substantially no change in tension applied to the one or more tensile members.

6. The method ofclaim 1, wherein the housing includes an internal flange disposed at the first end which prevents axial movement of the collet beyond the second position.

7. The method ofclaim 6, wherein the collet and the internal flange of the housing are further configured such that axial movement of the collet towards the first end of the housing will cause the internal flange to bear against the exterior surface of the collet, causing the collet to swage radially inwards around and against the one or more tensile members.

8. The method ofclaim 7, wherein the housing includes a transition section axially adjacent the internal flange configured to apply a radially inward force against the collet.

9. The method ofclaim 1, wherein the step of driving the sleeve down over the collet is carried out using an insertion instrument having an anchor connection mechanism which engages the housing, and a movable pushrod which engages the sleeve.

10. The method ofclaim 1 further comprising driving the sleeve until sleeve retention features of the housing and the sleeve become mutually engaged so as to prevent retraction of the sleeve.

11. The method ofclaim 10 when the retention features comprise predetermined dimensions of the sleeve and the housing which permit radial clearance between the sleeve and the housing in the first position and which create a radial interference between the sleeve and the housing in the second position.

12. A method for anchoring tensile members to a joint, comprising:

inserting a first tensile member having first and second ends into a first passage having first and second ends in a first bone;

securing the first end of the first tensile member in the first end of the first passage, using a first anchoring element;

inserting a second tensile member having first and second ends into a second passage having first and second ends in the first bone;

securing the first end of the second tensile member in the first end of the second passage, using a second anchoring element;

passing the second ends of both first and second tensile members through a third passage formed in a second bone;

providing a third anchoring element, comprising an anchor which includes:

a housing extending along a central axis between open first and second ends, and having a hollow interior;

a collet disposed in the hollow interior of the housing, the collet having a peripheral wall defining a central bore for accepting a tensile member therethrough and an exterior surface, wherein the collet is configured to be swaged around and against the tensile members;

a sleeve having a peripheral wall defining opposed interior and exterior surfaces, the sleeve disposed in the hollow interior of the housing and positioned generally axially adjacent to the collet, so as to be movable parallel to the central axis between first and second positions; and

wherein at least one of the exterior surface of the collet and the interior surface of the sleeve is tapered and the sleeve and the collet are arranged such that movement of the sleeve from the first position towards the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around and against the tensile members;

passing the second ends of the first and second tensile members through the central bore of the collet;

seating the housing into the second bone;

applying a first final tension to the first tensile member;

applying a second final tension to the second tensile member; and

driving the sleeve from the first position towards the second position, thus swaging the collet around the second ends of the first and second tensile members.

13. The method ofclaim 12 wherein the swaging causes substantially no change in the first and second final tensions applied to the first and second tensile members.

14. The method ofclaim 12 further comprising activating an insertion instrument to drive the sleeve down over the collet, thus swaging the collet around the second ends of the first and second tensile members.

15. The method ofclaim 12 further comprising, prior to the step of applying first and second final tensions to the first and second tensile members, respectively:

applying a first provisional tension to the first tensile member;

applying a second provisional tension to the second tensile member;

evaluating the first and second provisional tensions; and

increasing or decreasing at least one of the first and second provisional tensions.

16. The method ofclaim 15 wherein the step of evaluating the first and second provisional tensions includes moving a ligament or joint being repaired through some or all of its range of motion.

17. The method ofclaim 15 wherein the first and second final provisional tensions are applied to the first and second tensile members using a single instrument.

18. The method ofclaim 12 wherein the first and second anchoring elements are each one of: a suture button, a suture anchor, a bone plate, or an anchor.

19. The method ofclaim 12 wherein each of the first and second tensile members comprise a suture or a surgical cable.

20. The method ofclaim 12 wherein the first and second final tensions are applied to the first and second tensile members using a single instrument.

21. The method ofclaim 12 wherein the sleeve and the housing each include retention features, the retention features collectively configured to permit movement of the sleeve from the first position to the second position and to mutually engage each other so as to prevent the sleeve from moving out of the second position.

22. The method ofclaim 21 when the retention features comprise predetermined dimensions of the sleeve and the housing effective to permit radial clearance between the sleeve and the housing in the first position and to define a radial interference between the sleeve and the housing and the second position.

23. The method ofclaim 21 wherein the retention elements comprise locking tabs disposed on one of the housing and the sleeve, and an annular step disposed on the other of the housing and of the sleeve.

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